FLUZONE AND TRIVALENT INACTIVATED INFLUENZA VIRUS VACCINE IN ELDERLY SUBJECTS

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是比较接种单剂量标准流感疫苗或实验性高剂量疫苗的受试者的反应和抗体应答。实验性疫苗包含的三种流感病毒蛋白中每一种的量大约是标准疫苗中的四倍。标准疫苗和高剂量疫苗都含有美国FDA推荐用于2004-2005流感季节的三种流感病毒蛋白。高剂量流感疫苗被认为是研究性的。受试者一般健康状况良好，至少65岁，对鸡蛋无过敏，既往对流感疫苗无严重反应，未服用药物或有抑制免疫系统的基础疾病。 主要目的：接种后1个月通过血凝抑制试验（HAI）评价的免疫原性终点为：1）每组中血清抗体滴度至少为1：32的受试者比例（Baylor HAI测定）; 2）针对3种疫苗抗原中的每一种的血清HAI抗体的几何平均滴度（GMT）; 3）免疫前和免疫后血清样品之间血清HAI抗体滴度至少4倍增加的比率;和4）疫苗接种后约1个月，对于3种疫苗抗原中的每一种，血清HAI抗体滴度达到1：64和1：128（Baylor HAI测定）的受试者比例。 次要目的：反应原性终点是征集性局部和全身不良事件（AE）的频率和严重程度。对于每种疫苗，将确定每组中出现任何注射部位或全身症状的受试者数量和比例，以及出现中度至重度症状的受试者比例。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to compare reactions and antibody responses in subjects who are vaccinated with either a single dose of a standard flu vaccine or the experimental high dose vaccine. The experimental vaccine includes approximately four times the amount of each of three influenza virus proteins that are in the standard vaccine. Both the standard vaccine and the high dose vaccine contain the three influenza virus proteins that were recommended by the U.S. FDA for the 2004-2005 influenza season. The high dose influenza vaccine is considered investigational. Subjects will be in good general health, at least 65 years old, no allergies to eggs, no previous severe reactions to influenza vaccines, and not taking drugs or have underlying conditions that suppress the immune system. Primary Objectives: The immunogenicity endpoints to be evaluated by haemagglutination-inhibition assay (HAI) at 1 month post-vaccination are: 1) the proportion of subjects in each group who achieve a serum antibody titer of at least 1:32 (Baylor HAI assay) for each of the 3 vaccine antigens approximately 1 month after vaccination; 2) the geometric mean titer (GMT) of serum HAI antibody against each of the 3 vaccine antigens; 3) the rates of at least 4-fold increases in serum HAI antibody titer between pre-immunization and post-immunization serum samples; and 4) the proportion of subjects who achieve serum HAI antibody titers of 1:64 and 1:128 (Baylor HAI assay) for each of the 3 vaccine antigens approximately 1 month after vaccination. Secondary Objectives: The reactogenicity endpoints are the frequency and severity of solicited local and systemic adverse events (AE). The number and proportions of subjects in each group experiencing any injection site or systemic symptoms, and the proportions of subjects who experience moderate-to-severe symptoms will be determined for each vaccine.